Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:17 PM
Ignite Modification Date: 2025-12-25 @ 1:38 PM
NCT ID: NCT02066792
Description: Participants were asked if they had experienced any injuries or illnesses at the beginning of each study visit.
Frequency Threshold: 0
Time Frame: Data for adverse events was collected at each assessment point over the course of the study (e.g., in-person screening, baseline appointment, sessions 1-5, and the 1-week, 1-month, and 3-month follow-ups).
Study: NCT02066792
Study Brief: Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-Session DCS Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session). D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction. Placebo: Sugar pill 0 None 0 38 0 38 View
Placebo Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session). Placebo: Sugar pill 0 None 1 38 0 38 View
Non-Tailored Post-Session DCS Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session). D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction. Placebo: Sugar pill 0 None 0 36 0 36 View
Tailored Post-Session DCS Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). DCS will be administered if the session is deemed a success. D-Cycloserine: D-cycloserine is a medication thought to be associated with fear extinction. Placebo: Sugar pill 0 None 0 40 0 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious Adverse Event SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):